PainMuSoCaNCT05204043
Peter Hess® Sound Massage for Reducing Anxiety and Pain in Cardiac Surgery
A study testing Peter Hess® sound massage, Music relaxation Music Care® and Questionnaires in people with Pain and Pain, Postoperative, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Cardiac surgery patients often undergo anxiousness and pain. Before surgery, anxiety is often caused by the idea of sternotomy, extracorporeal circulation, fear of post-operative pain, and even death. After surgery anxiety and pain can be the consequences of operative and peri-operative procedures. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Pain, Pain, Postoperative, Pain, Chest
- What is being tested?
- Peter Hess® sound massage, Music relaxation Music Care® and Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 40 and 70 years old
- Hospitalized for a coronary bypass
- That has given his written consent
- Affiliated to a French social security system or entitled to a social security benefit.
Who cannot join
- Emergency coronary bypass surgery
- Impaired ventricular function (ejection fraction < 45%)
- Combined surgery
- Patient with chronic dialysis
- Diagnosed with severe depression
- Patient in a psychotic state
Show all 17Show fewer
- Patient with chronic pain
- Patient incapable of giving his written consent
- Patient deprived of liberty by judicial decision or benefiting from legal protection (under guardianship or curatorship)
- Patient on AME
- Participation in other interventional research involving humans, or being in the period of exclusion from previous research involving humans, if applicable.
- Pregnant or breastfeeding woman
- Patient with pacemaker
- Patient with implanted metallic medical devices
- Recently operated patient
- Patient with hearing epilepsy
- Tinnitus patient
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Peter Hess® Sound Massage Versus Music Care® Relaxation for the Management of Anxiety and Pain in Patients Undergoing Coronary Artery Bypass Surgery in Thoracic and Cardiovascular Surgery: a Comparative Controlled and Randomised Study.
Cardiac surgery patients often undergo anxiousness and pain. Before surgery, anxiety is often caused by the idea of sternotomy, extracorporeal circulation, fear of post-operative pain, and even death. After surgery anxiety and pain can be the consequences of operative and peri-operative procedures. The investigators believe that reducing stress and pain by a relaxation therapy would lead to better stay in hospital and a better recovery after surgery.
Music Care® relaxation technique consists into listening to an audio relaxing soundtrack chosen by the patient. This technique has already proven with several clinical studies its efficiency for reducing pain and anxiety in hospital.
Read more
The research consists of comparing this technique to Peter Hess® sound massage for reducing pain and anxiety.
The Peter Hess® sound massage is a holistic relaxation technique that uses sound vibrations generated by therapeutic singing bowls.
Patients will be randomized in one of the two groups (Music Care® or Peter Hess®).
Read the detailed description
- Cardiac surgery patients often undergo anxiousness and pain. Before surgery, anxiety is often caused by the idea of sternotomy, extracorporeal circulation, fear of post-operative pain, and even death. After surgery anxiety and pain can be the consequences of operative and peri-operative procedures. The investigators believe that reducing stress and pain by a relaxation therapy would lead to better stay in hospital and a better recovery after surgery.
- Design of the study: Controlled randomized single blind clinical trial / Interventional research protocol implying human being that doesn't involve any health product
- Patients will be randomized in one of the two following groups:
- Peter Hess® sound massage, a relaxation technic using singing bowls' sound vibrations The Peter Hess® sound massage is a holistic relaxation technique (body and mind) that uses sound vibrations generated by therapeutic singing bowls. Its efficiency and adaptability make it a complementary method that can be pertinent for many hospital departments, both for patients and caregivers.
- Music Care® relaxation technique, a validated Non-Medicinal Intervention which is a pyscho-musical relaxation technique using audio relaxation music diffused in dedicated headphone. The audio relaxing soundtracks are chosen by the patient. Music Care® technique has already proven with several clinical studies its efficiency for reducing pain and anxiety in hospital.
- Main Objective: Prove a better efficiency of the Peter Hess® sound massage for reducing anxiety compared to Music Care® relaxation technique.
- Main criteria: difference between the two groups on anxiety scores' variation (measured by STAI) between preoperative visit (J-1) and postoperative visit (J+7)
- Conditions
- Pain, Pain, Postoperative, Pain, Chest, Anxiety, Anxiety Postoperative, Thoracic Surgery
- Being tested
- Peter Hess® sound massage, Music relaxation Music Care®, Questionnaires
- Keywords
- Peter Hess, Music Care, Sound massage, sound therapy, music therapy, singing bowls, vibrations, relaxation, coronary bypass, cardiac surgery, cardiology, music
- Medical subject headings
- Pain, Pain, Postoperative, Chest Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peter Hess® sound massageOther
The Peter Hess® sound massage uses sound vibrations generated by therapeutic singing bowls. Peter Hess' methods act far from a traumatised area, far from the pain. It will be given on the patient's bed for 30 minutes.
Music relaxation Music Care®Other
The patient chooses his music preferences and receive the music relaxation in bed for 30 minutes.
QuestionnairesOther
- State Trait Anxiety Inventory (STAI)
- Pain assessment - Visual Analogic Scale (from 0 to 10).
| Study group | Role | What they receive |
|---|---|---|
| Peter Hess® sound massage | Experimental | Peter Hess® sound massage using bowls dedicated to this technique. Receives: Other: Peter Hess® sound massage; Other: Questionnaires |
| Music relaxation Music Care® | Experimental | The patient chooses his music preferences and receive the music relaxation. Receives: Other: Music relaxation Music Care®; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Trait Anxiety Inventory (STAI-A) score, between the 2 groups of patients
Questionnaire based on a 4-point Likert scale and composed of 20 questions on a self-report basis.
Higher scores are correlated with higher levels of anxiety.
Measured: At Day7 (after surgery)
Secondary outcomes (10)
State Trait Anxiety Inventory (STAI-A) score, in each group
Questionnaire based on a 4-point Likert scale and composed of 20 questions on a self-report basis.
Higher scores are correlated with higher levels of anxiety.
Measured: At Day-1 (day before surgery) and after surgery (at Day2 and Day4)
Consumption of anxiolytic drugs
Drugs prescriptions will be reported
Measured: Through study completion, an average of 7 days
Pain assessment
Visual Analogic Scale (score from 0 to 10). Higher scores are correlated with higher levels of pain.
VAS filled twice at Day-1, Day2 and Day4 (before and after the intervention (Peter Hess sound massage / Music Care)) VAS filled once at Day3 and Day7
Measured: At Day-1, Day2, Day3, Day4 and Day7.
Consumption of antalgics
Drugs prescriptions will be reported
Measured: Through study completion, an average of 7 days
Consumption of anti-inflammatory
Drugs prescriptions will be reported
Measured: Through study completion, an average of 7 days
Demand of care in physiotherapy
Number of care in physiotherapy will be reported
Measured: Through study completion, an average of 7 days
Blood pressure
Variation of blood pressure before and after Peter Hess sound massage or Music Care relaxation technique (depending of the arm) will be assessed
Measured: At Day-1 (day before surgery) and after surgery (at Day2 and Day4)
Cardiac frequency
Variation of cardiac frequency before and after Peter Hess sound massage or Music Care relaxation technique (depending of the arm) will be assessed
Measured: At Day-1 (day before surgery) and after surgery (at Day2 and Day4)
Length of hospitalisation
Length of hospitalisation
Measured: At Day7 (end of participation)
Sides effect
Side effect reporting
Measured: Through study completion, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal LEPRINCE, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204043
- Sponsor's protocol ID
- APHP190384
- Other IDs
- 2020-A02371-38
- Acronym
- MuSoCa
- Status last verified
- Dec 2021
- First submitted
- 20 Dec 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peter Hess® Sound Massage Versus Music Care® Relaxation for the Management of Anxiety and Pain in Patients Undergoing Coronary Artery Bypass Surgery in Thoracic and Cardiovascular Surgery: a Comparative Controlled and Randomised Study.
- ClinicalTrials.gov ID
- NCT05204043
- Acronym / sponsor ID
- MuSoCa / APHP190384
- Conditions
- Pain, Pain, Postoperative, Pain, Chest, Anxiety, Anxiety Postoperative, Thoracic Surgery
- Keywords
- Peter Hess, Music Care, Sound massage, sound therapy, music therapy, singing bowls, vibrations, relaxation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiac surgery patients often undergo anxiousness and pain. Before surgery, anxiety is often caused by the idea of sternotomy, extracorporeal circulation, fear of post-operative pain, and even death. After surgery anxiety and pain can be the consequences of operative and peri-operative procedures. The investigators believe that reducing stress and pain by a relaxation therapy would lead to better stay in hospital and a better recovery after surgery.
Music Care® relaxation technique consists into listening to an audio relaxing soundtrack chosen by the patient. This technique has already proven with several clinical studies its efficiency for reducing pain and anxiety in hospital.
The research consists of comparing this technique to Peter Hess® sound massage for reducing pain and anxiety.
The Peter Hess® sound massage is a holistic relaxation technique that uses sound vibrations generated by therapeutic singing bowls.
Patients will be randomized in one of the two groups (Music Care® or Peter Hess®).
Detailed description
- Cardiac surgery patients often undergo anxiousness and pain. Before surgery, anxiety is often caused by the idea of sternotomy, extracorporeal circulation, fear of post-operative pain, and even death. After surgery anxiety and pain can be the consequences of operative and peri-operative procedures. The investigators believe that reducing stress and pain by a relaxation therapy would lead to better stay in hospital and a better recovery after surgery.
- Design of the study: Controlled randomized single blind clinical trial / Interventional research protocol implying human being that doesn't involve any health product
- Patients will be randomized in one of the two following groups:
- Peter Hess® sound massage, a relaxation technic using singing bowls' sound vibrations The Peter Hess® sound massage is a holistic relaxation technique (body and mind) that uses sound vibrations generated by therapeutic singing bowls. Its efficiency and adaptability make it a complementary method that can be pertinent for many hospital departments, both for patients and caregivers.
- Music Care® relaxation technique, a validated Non-Medicinal Intervention which is a pyscho-musical relaxation technique using audio relaxation music diffused in dedicated headphone. The audio relaxing soundtracks are chosen by the patient. Music Care® technique has already proven with several clinical studies its efficiency for reducing pain and anxiety in hospital.
- Main Objective: Prove a better efficiency of the Peter Hess® sound massage for reducing anxiety compared to Music Care® relaxation technique.
- Main criteria: difference between the two groups on anxiety scores' variation (measured by STAI) between preoperative visit (J-1) and postoperative visit (J+7)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peter Hess® sound massage | Experimental | Other: Peter Hess® sound massage, Other: QuestionnairesPeter Hess® sound massage using bowls dedicated to this technique. |
| Music relaxation Music Care® | Experimental | Other: Music relaxation Music Care®, Other: QuestionnairesThe patient chooses his music preferences and receive the music relaxation. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients between 40 and 70 years old
- Hospitalized for a coronary bypass
- That has given his written consent
- Affiliated to a French social security system or entitled to a social security benefit.
Key exclusion criteria (17 listed)
- Emergency coronary bypass surgery
- Impaired ventricular function (ejection fraction < 45%)
- Combined surgery
- Patient with chronic dialysis
- Diagnosed with severe depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peter Hess® sound massageThe Peter Hess® sound massage uses sound vibrations generated by therapeutic singing bowls. Peter Hess' methods act far from a traumatised area, far from the pain. It will be given on the patient's bed for 30 minutes. | Other | Peter Hess® sound massage |
| Music relaxation Music Care®The patient chooses his music preferences and receive the music relaxation in bed for 30 minutes. | Other | Music relaxation Music Care® |
| Questionnaires* State Trait Anxiety Inventory (STAI) * Pain assessment - Visual Analogic Scale (from 0 to 10). | Other | Music relaxation Music Care®, Peter Hess® sound massage |
Primary outcome
State Trait Anxiety Inventory (STAI-A) score, between the 2 groups of patients
Time frame: At Day7 (after surgery)
Questionnaire based on a 4-point Likert scale and composed of 20 questions on a self-report basis. Higher scores are correlated with higher levels of anxiety.
10 secondary outcomes
State Trait Anxiety Inventory (STAI-A) score, in each group
Time frame: At Day-1 (day before surgery) and after surgery (at Day2 and Day4)
Consumption of anxiolytic drugs
Time frame: Through study completion, an average of 7 days
Pain assessment
Time frame: At Day-1, Day2, Day3, Day4 and Day7.
Consumption of antalgics
Time frame: Through study completion, an average of 7 days
Consumption of anti-inflammatory
Time frame: Through study completion, an average of 7 days
Demand of care in physiotherapy
Time frame: Through study completion, an average of 7 days
Blood pressure
Time frame: At Day-1 (day before surgery) and after surgery (at Day2 and Day4)
Cardiac frequency
Time frame: At Day-1 (day before surgery) and after surgery (at Day2 and Day4)
Length of hospitalisation
Time frame: At Day7 (end of participation)
Sides effect
Time frame: Through study completion, an average of 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal LEPRINCE, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing Peter Hess® sound massage, Music relaxation Music Care® and Questionnaires in people with Pain and Pain, Postoperative, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascal LEPRINCE, PU-PH (01 42 16 56 32 ext. +33, pascal.leprince@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Trait Anxiety Inventory (STAI-A) score, between the 2 groups of patients (time frame: At Day7 (after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.